Rexall Ice Cold Analgesic

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains in muscles and joints associated with various conditions, including simple backache, sprains, arthritis, strains, sports injuries, and bruises.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The affected area should be cleaned prior to the application of the product. For adults and children aged 2 years and older, the product may be applied to the affected area up to 3 to 4 times daily. It is important to ensure that the application does not exceed this frequency to maintain safety and efficacy.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used in conjunction with other topical pain relievers due to the potential for increased irritation or adverse effects. Application with heating pads or heating devices is contraindicated as it may enhance absorption and lead to increased risk of systemic effects.

Additionally, the product must not be applied in or near the eyes to prevent irritation or injury. It is also contraindicated for use on wounds or damaged skin, as this may exacerbate the condition or lead to infection. Lastly, tight bandaging of the application site is not recommended, as it may restrict circulation and cause further complications.

Warnings and Precautions

For external use only. It is imperative that this product is applied solely to the skin and not ingested.

General precautions must be observed to ensure safety. This product should be kept out of reach of children and pets. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Healthcare professionals should instruct patients to discontinue use and consult a physician if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, or if any redness or irritation develops at the site of application.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, if redness or irritation develops, medical advice should be sought.

Drug Interactions

Co-administration of this medication with other topical pain relievers is contraindicated due to the potential for increased local irritation or adverse effects. It is advised to avoid the simultaneous use of heating pads or other heating devices, as this may enhance the risk of skin irritation or burns.

Monitoring for signs of local adverse reactions is recommended when this medication is used, particularly in patients who may be using other topical agents or heat sources.

Packaging & NDC

Below are the non-prescription pack sizes of Rexall Ice Cold Analgesic (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be kept out of reach of children. For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be warranted based on clinical judgment.

Overdosage

In the context of overdosage, it is important to note that there is currently no specific information available regarding the effects or management of an overdose for this medication. Healthcare professionals are advised to exercise caution and consider the individual patient's circumstances when faced with a potential overdosage scenario.

In the absence of detailed guidance, it is recommended that healthcare providers monitor the patient closely for any unusual symptoms or adverse reactions that may arise. Supportive care should be initiated as necessary, and symptomatic treatment should be provided based on the clinical presentation of the patient.

In cases of suspected overdosage, it is prudent to consult local poison control centers or relevant medical authorities for further assistance and guidance on management strategies.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children and pets to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use this product in conjunction with other topical pain relievers, as this may increase the risk of adverse effects. Additionally, they should avoid using the product with heating pads or other heating devices, as this could lead to increased irritation or burns.

Healthcare providers should counsel patients to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Patients should also be advised to stop using the product and seek medical advice if they experience any redness or irritation.

It is important to instruct patients not to apply the product in or near the eyes, and to avoid applying it to wounds or damaged skin. Furthermore, patients should be cautioned against tightly bandaging the area where the product is applied, as this may exacerbate irritation or other side effects.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light to prevent degradation. After opening, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is also important to instruct patients to keep the product out of reach of children and pets, and to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Rexall Ice Cold Analgesic, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)